D-0244-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 21, 2018
- Initiation Date
- September 27, 2018
- Termination Date
- October 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,362 vials
Product Description
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
Reason for Recall
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Distribution Pattern
Product was distributed throughout the United States, including Hawaii and Puerto Rico.
Code Information
Lot # 31323147B, exp. date 01/2019